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Procedure

Uterine Manipulation in Surgery for Endometrial Cancer (MAN-U Trial)

N/A

Recruiting

Research Sponsored by Anthony Costales, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must be greater than or equal to 18 years old

ECOG performance status 0-2 (see appendix 1)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up intra-operative and up to 30 days post-surgery

Awards & highlights

MAN-U Trial Summary

This trial will compare two groups of women undergoing surgery for early-stage uterine cancer, to see if there is a difference in the rate of cancer cells present in the fluid when a uterine manipulator is used.

Who is the study for?

This trial is for adults over 18 with suspected early stage endometrial cancer, who are fit enough for minimally invasive surgery (MIS) and have no signs of cancer spread outside the uterus. They must be able to follow the study's procedures and not have had pelvic radiation or progesterone therapy for their cancer.Check my eligibility

What is being tested?

The study compares outcomes in patients undergoing MIS for early stage uterine cancer using a uterine manipulator (UM) versus those without UM. It aims to see if there's a difference in the presence of cancer cells in surgical fluid between these two methods.See study design

What are the potential side effects?

While specific side effects aren't listed, typical risks associated with minimally invasive gynecologic surgery may include bleeding, infection, injury to surrounding organs, pain, and complications related to anesthesia.

MAN-U Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of the day.

MAN-U Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after uterine manipulator placement in the manipulator group or prior to the initiation of the hysterectomy procedure in the non-manipulator group

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after uterine manipulator placement in the manipulator group or prior to the initiation of the hysterectomy procedure in the non-manipulator group

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after uterine manipulator placement in the manipulator group or prior to the initiation of the hysterectomy procedure in the non-manipulator group for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Positive peritoneal cytology (PC)

Secondary outcome measures

Extent of lymph node metastases

Lymphovascular space invasion (LVSI)

Operative time

+3 more

MAN-U Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Surgery With UM (Arm MAN UA)Experimental Treatment1 Intervention

Subjects that undergo a MIS approach with a uterine manipulator (experimental arm)

Group II: Surgery Without UM (Arm Control)Active Control1 Intervention

Subjects that undergo a MIS approach without a uterine manipulator (control arm)

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Anthony Costales, MDLead Sponsor

The Cleveland ClinicOTHER

1,030 Previous Clinical Trials

1,365,280 Total Patients Enrolled

Media Library

Surgery without UM (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04586959 — N/A

Endometrial Cancer Research Study Groups: Surgery Without UM (Arm Control), Surgery With UM (Arm MAN UA)

Endometrial Cancer Clinical Trial 2023: Surgery without UM Highlights & Side Effects. Trial Name: NCT04586959 — N/A

Surgery without UM (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04586959 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an eligibility criteria for enrolling in this clinical research?

"This clinical research requires 278 patients with endometrial cancer whose age is no less than 18 and not more than 90. To qualify, applicants must have pre-operative imaging results that are unrelated to extra-uterine disease (if applicable), a CA 125 test result within the laboratory's normal values (optional), and an ECOG performance status of 0 to 2 (see appendix 1)."

Answered by AI

Are any new participants being accepted for this experiment?

"Data hosted on clinicaltrials.gov demonstrates that this study is presently recruiting new patients; it was initially posted on May 21 2021 and recently updated September 6th 2022."

Answered by AI

Is there a minimum age requirement to be considered for enrollment in this study?

"This research is open to any patient who has reached the age of majority and is below their ninetieth birthday."

Answered by AI

To what extent is this experiment being tested with human subjects?

"Affirmative. As found on clinicaltrials.gov, this research study is currently enrolling participants and has been since May 21st 2021. The trial requires a total of 278 patients to be recruited from 5 individual medical sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer

Anthony Costales, MD 2021. "Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04586959.